Back to resultsUtilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SLE@Duke
Sponsored by
About this trial
This is an interventional health services research trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria:
- All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
- Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
- All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1*, M32.8, M32.9) in the EMR.
Exclusion Criteria:
- New patients will be excluded
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SLE@Duke
Arm Description
Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 & 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.
Outcomes
Primary Outcome Measures
Number of Patients' Rheumatologists Using SLE@Duke
Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 & 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 & Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.
Length of Clinic Visits
Collected from EMR (electronic medical record).
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
Collected from EMR (electronic medical record).
Number of Lupus Patients With Type 2 SLE Treatment in Note
Collected from EMR (electronic medical record).
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
Collected from EMR (electronic medical record).
Difference in Perceived Quality of Visit, as Measured by Patient Survey
Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 & Type 2 lupus with me today."
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey
Discussion of the Type 1 & 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 & 2 SLE Model with the patient."
Change in Acceptability of SLE@Duke, as Measured by Provider Survey
Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey
Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Change in Feasibility of SLE@Duke, as Measured by Provider Survey
Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Secondary Outcome Measures
Full Information
NCT ID
NCT05426902
First Posted
June 16, 2022
Last Updated
September 5, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT05426902
Brief Title
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Official Title
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 & 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus.
This record represents Aim 3 of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLE@Duke
Arm Type
Experimental
Arm Description
Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 & 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
SLE@Duke
Intervention Description
SLE@Duke is a set of tools to implement the Type 1 & 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 & 2 SLE.
Primary Outcome Measure Information:
Title
Number of Patients' Rheumatologists Using SLE@Duke
Description
Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 & 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 & Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Length of Clinic Visits
Description
Collected from EMR (electronic medical record).
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
Description
Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
Description
Collected from EMR (electronic medical record).
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Number of Lupus Patients With Type 2 SLE Treatment in Note
Description
Collected from EMR (electronic medical record).
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
Description
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time Frame
4 weeks
Title
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
Description
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time Frame
4 weeks
Title
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
Description
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time Frame
4 weeks
Title
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
Description
Collected from EMR (electronic medical record).
Time Frame
Intervention period (month 2), month 5
Title
Difference in Perceived Quality of Visit, as Measured by Patient Survey
Description
Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
Description
The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 & Type 2 lupus with me today."
Time Frame
Intervention period (month 2)
Title
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
Description
Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey
Description
Discussion of the Type 1 & 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 & 2 SLE Model with the patient."
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Change in Acceptability of SLE@Duke, as Measured by Provider Survey
Description
Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey
Description
Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Time Frame
Baseline (month 1), intervention period (month 2)
Title
Change in Feasibility of SLE@Duke, as Measured by Provider Survey
Description
Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Time Frame
Baseline (month 1), intervention period (month 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1*, M32.8, M32.9) in the EMR.
Exclusion Criteria:
New patients will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Eudy, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
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